System and method for anesthetizing eustachian tube

ABSTRACT

A system for delivering a fluid to a Eustachian tube (ET) of a patient includes a guide member and a tubular member. The guide member includes a shaft having a proximal portion, a distal portion, and a bend at the distal portion. The bend is configured to provide access to an opening in the ET. The system further includes a tubular member comprising a proximal end, a distal end, and a lumen extending therebetween. The tubular member is sized to fit within the ET. One or both of the tubular member and the guide member comprises a first stop member configured to engage the other of the tubular member or the guide member. The first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

BACKGROUND

Referring to FIGS. 1-2, the ear (10) is divided into three parts: anexternal ear (12), a middle ear (14) and an inner ear (16). The externalear (12) consists of an auricle (18) and ear canal (20) that gathersound and direct it toward a tympanic membrane (22) (also referred to asthe eardrum) located at an inner end (24) of the ear canal (20). Themiddle ear (14) lies between the external and inner ears (12, 16) and isconnected to the back of the throat by a Eustachian tube (ET) (26),which serves as a pressure equalizing valve between the ear (10) and thesinuses. The ET (26) terminates in a pharyngeal ostium (28) in thenasopharynx region (30) of the throat (32). In addition to the eardrum(22), the middle ear (14) also consists of three small ear bones(ossicles): the malleus (34) (hammer), incus (36) (anvil) and stapes(38) (stirrup). These bones (34, 36, 38) transmit sound vibrations tothe inner ear (16) and thereby act as a transformer, converting soundvibrations in the canal (20) of the external ear (12) into fluid wavesin the inner ear (16). These fluid waves stimulate several nerve endings(40) that, in turn, transmit sound energy to the brain where it isinterpreted.

The ET (26) is a narrow, one-and-a-half inch long channel connecting themiddle ear (14) with the nasopharynx (30), the upper throat area justabove the palate, in back of the nose. The ET (26) functions as apressure equalizing valve for the middle ear (14), which is normallyfilled with air. When functioning properly, the ET (26) opens for afraction of a second periodically (about once every three minutes) inresponse to swallowing or yawning. In so doing, it allows air into themiddle ear (14) to replace air that has been absorbed by the middle earlining (mucous membrane) or to equalize pressure changes occurring onaltitude changes. Anything that interferes with this periodic openingand closing of the ET (26) may result in hearing impairment or other earsymptoms.

Obstruction or blockage of the ET (26) results in a negative middle ear(14) pressure, with retraction (sucking in) of the eardrum (22). Inadults, this is usually accompanied by some ear discomfort, a fullnessor pressure feeling and may result in a mild hearing impairment and headnoise (tinnitus). There may be no symptoms in children. If theobstruction is prolonged, fluid may be drawn from the mucous membrane ofthe middle ear (14), creating a condition referred to as serous otitismedia (fluid in the middle ear). This occurs frequently in children inconnection with an upper respiratory infection and accounts for thehearing impairment associated with this condition.

A lining membrane (mucous membrane) of the middle ear (14) and ET (26)is connected with, and is the same as, the membrane of the nose (42),sinuses (44) and throat (32). Infection of these areas results in mucousmembrane swelling which in turn may result in obstruction of the ET(26). This is referred to as serous otitis media, which as discussedabove is essentially a collection of fluid in the middle ear (14).Serous otitis media can be acute or chronic, and may be the result ofblockage of the pharyngeal ostium (28) of the ET (26), which leads tothe accumulation of fluid in the middle ear (14). In the presence ofbacteria, this fluid may become infected, leading to an acutesuppurative otitis media (infected or abscessed middle ear). Wheninfection does not develop, the fluid remains until the ET (26) againbegins to function normally, at which time the fluid is absorbed ordrains down the tube into the throat (32) through the ET (26) pharyngealostium (28).

Chronic serous otitis media may result from longstanding ET blockage, orfrom thickening of the fluid so that it cannot be absorbed or draineddown the ET (26). This chronic condition may lead to hearing impairment.There may be recurrent ear pain, especially when the individual catchesa cold. Fortunately, serous otitis media may persist for many yearswithout producing any permanent damage to the middle ear mechanism. Thepresence of fluid in the middle ear (14), however, makes it verysusceptible to recurrent acute infections. These recurrent infectionsmay result in middle ear damage.

When the ET (26) contains a build-up of fluid, a number of things mayoccur. First, the body may absorb the air from the middle ear (14),causing a vacuum to form that tends to pull the lining membrane and eardrum (22) inwardly, causing pain. Next, the body may replace the vacuumwith more fluid which tends to relieve the pain, but the patient canexperience a fullness sensation in the ear (10). Treatment of thiscondition with antihistamines and decongestants can take many weeks tobe fully effective. Finally, the fluid can become infected, which canlead to pain, illness, and temporary hearing loss. If the inner ear (14)is affected, the patient may feel a spinning or turning sensation(vertigo). The infection may be treated with antibiotics.

However, even if antihistamines, decongestants, and antibiotics are usedto treat an infection or other cause of fluid build-up in the middle ear(14), these treatments may not immediately resolve the pain anddiscomfort caused by the buildup of fluid in the middle ear (14). Themost immediate relief may be felt by the patient if the fluid can beremoved from the ET (26).

Antibiotic treatment of middle ear infections may result in normalmiddle ear function within three to four weeks. During the healingperiod, the patient can experience varying degrees of ear pressure,popping, clicking and fluctuation of hearing, occasionally with shootingpain in the ear. Resolution of the infection may leave the patient withuninfected fluid in the middle ear (14), localized in the ET (26).

Fluid build-up caused by these types of infections may be treatedsurgically. The primary objective of surgical treatment of chronicserous otitis media may be to reestablish ventilation of the middle ear,keeping the hearing at a normal level and preventing recurrent infectionthat might damage the eardrum membrane and middle ear bones. One methodto opening the ET (26) includes the “Valsalva” maneuver, accomplished byforcibly blowing air into the middle ear (14) while holding the nose,often called popping the ear. This method may be effective for openingthe ET (26) but it may not clear the accumulated fluid from the middleear (14) and is essentially a temporary fix when fluid is present in themiddle ear (14).

Methods for treating the middle ear (14) and the ET (26) include thosedisclosed in U.S. Patent Pub. No. 2010/0274188, entitled “Method andSystem for Treating Target Tissue within the ET,” published on Oct. 28,2010, the disclosure of which is incorporated by reference herein; U.S.Patent Pub. No. 2013/0274715, entitled “Method and System for EustachianTube Dilation,” published on Oct. 17, 2013, the disclosure of which isincorporated by reference herein; and U.S. patent application Ser. No.14/317,269, entitled “Vent Cap for a Eustachian Tube Dilation System,”filed Jun. 27, 2014, the disclosure of which is incorporated byreference herein. As described in those references, functioning of theET (26) may be improved by dilating the ET (26) with an expandabledilator instrument.

While a variety of surgical instruments have been made and used, it isbelieved that no one prior to the inventors has made or used theinvention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a cross-sectional view of a human ear showing the inner,middle and outer ear portions and the Eustachian tube connecting themiddle ear with the nasopharynx region of the throat.

FIG. 2 depicts a cross-sectional view of a human head showing thenasopharynx region of the throat illustrated in FIG. 1 containing thepharyngeal ostium of the Eustachian tube illustrated in FIG. 1.

FIG. 3A depicts a side elevational view of an exemplary guide catheterthat may be used to position the dilation catheter of FIG. 5A.

FIG. 3B depicts a cross-sectional view of the guide catheter shown inFIG. 3A, taken along line 3B-3B of FIG. 3A.

FIG. 4 depicts an enlarged view of the distal end of the guide cathetershown in FIG. 3A.

FIG. 5A depicts a side elevational view of a balloon dilation catheterthat may be used with the guide catheter of FIG. 3A.

FIG. 5B depicts a cross-sectional view of the balloon dilation cathetershown in FIG. 5A, taken along line 5B-5B of FIG. 6.

FIG. 6 depicts an enlarged view of the distal end of the balloondilation catheter shown in FIG. 5A.

FIG. 7 depicts a side elevational view of another exemplary guidecatheter that may be used to position the dilation catheter of FIG. 5A.

FIG. 8 depicts a perspective view of an exemplary endoscope suitable foruse with the guide catheter of FIG. 3A and/or the balloon dilationcatheter of FIG. 5A.

FIG. 9 depicts a side elevational view of the distal end of theendoscope of FIG. 8, showing an exemplary range of viewing angles.

FIG. 10A depicts a cross-sectional view of a guide catheter, a ballooncatheter, and an endoscope being positioned in relation to a Eustachiantube of a patient, with a guidewire disposed in the Eustachian tube.

FIG. 10B depicts a cross-sectional view of the guide catheter, ballooncatheter, and endoscope of FIG. 10A, with a balloon of the ballooncatheter being expanded to dilate the Eustachian tube.

FIG. 11 depicts a side elevational view of an exemplary needle that maybe used with the guide catheter of FIG. 3A or the guide catheter FIG. 7to deliver fluids to the Eustachian tube.

FIG. 12 depicts a side elevational view of an exemplary alternativeneedle that may be used with the guide catheter of FIG. 3A or the guidecatheter FIG. 7 to deliver fluids to the Eustachian tube.

FIG. 13 depicts a side elevational view of another exemplary alternativeneedle that may be used with the guide catheter of FIG. 3A or the guidecatheter FIG. 7 to deliver fluids to the Eustachian tube.

FIG. 14 depicts a side elevational view of an exemplary sheath that maybe used with the needle of FIG. 13 and the guide catheter of FIG. 3A orthe guide catheter FIG. 7 to deliver fluids to the Eustachian tube.

FIG. 15A depicts a side elevational view of the needle of FIG. 13 andthe sheath of FIG. 14 having been directed into the guide catheter ofFIG. 3A, with a hub of the sheath abutted against a handle portion ofthe guide catheter, and the needle being in a proximal, retractedposition.

FIG. 15B depicts a side elevational view of the needle of FIG. 13 andthe sheath of FIG. 14 having been directed into the guide catheter ofFIG. 3A, with the hub of the sheath abutted against a handle portion ofthe guide catheter and the needle being in a distal, exposed position.

FIG. 16 depicts a side elevational view of an exemplary alternativeguide catheter.

FIG. 17 depicts a side elevational view of another exemplary alternativeneedle that may be used with the guide catheter of FIG. 16.

FIG. 18 depicts a side elevational view of another exemplary alternativeneedle that may be used to deliver fluids to the Eustachian tube.

FIG. 19 depicts an enlarged side view of the distal end of the needle ofFIG. 18.

FIG. 20 depicts a cross-sectional view of the needle of FIG. 18, takenalong line 20-20 of FIG. 19.

FIG. 21A depicts a side elevational view of an exemplary alternativeballoon dilation catheter that may be used with the guide catheter ofFIG. 3A or the guide catheter of FIG. 16.

FIG. 21B depicts a cross-sectional view of the balloon dilation catheterof FIG. 21A, taken along line 21B-21B of FIG. 22.

FIG. 22 depicts an enlarged side elevational view of the distal end ofthe balloon dilation catheter shown in FIG. 21A.

FIG. 23A depicts an enlarged side elevational view of an exemplaryalternative balloon dilation catheter that may be used with the guidecatheter of FIG. 3A or the guide catheter of FIG. 16.

FIG. 23B depicts a cross-sectional view of the balloon dilation catheterof FIG. 23A, taken along line 23B-23B of FIG. 23A.

FIG. 23C depicts a cross-sectional view of the balloon dilation catheterof FIG. 23A, taken along line 23C-23C of FIG. 23A.

FIG. 24A depicts an enlarged side elevational view of an exemplaryalternative balloon dilation catheter that may be used with the guidecatheter of FIG. 3A or the guide catheter of FIG. 16.

FIG. 24B depicts a cross-sectional view of the balloon dilation catheterof FIG. 24A, taken along line 24B-24B of FIG. 24A.

FIG. 24C depicts a cross-sectional view of the balloon dilation catheterof FIG. 24A, taken along line 24C-24C of FIG. 24A.

FIG. 25A depicts an enlarged side elevational view of an exemplaryalternative balloon dilation catheter that may be used with the guidecatheter of FIG. 3A or the guide catheter of FIG. 16.

FIG. 25B depicts a cross-sectional view of the balloon dilation catheterof FIG. 25A, taken along line 25B-25B of FIG. 25A.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictexemplary examples for the purpose of explanation only and are notintended to limit the scope of the invention. The detailed descriptionillustrates by way of example, not by way of limitation, the principlesof the invention. This description will clearly enable one skilled inthe art to make and use the invention, and describes several examples,adaptations, variations, alternative and uses of the invention,including what is presently believed to be the best mode of carrying outthe invention.

As used herein, the terms “about” and “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein.

I. EXEMPLARY EUSTACHIAN TUBE DILATION CATHETER SYSTEM

One example of a treatment that may be performed to treat an ET (26)that does not provide sufficient communication between the middle ear(14) and the pharyngeal ostium (28) includes accessing and dilating theET (26) using a guide catheter (100) and a balloon dilation catheter(200), examples of which are shown in FIGS. 3A-6. Guide catheter (100)of the present example includes an elongate tubular shaft (102) that hasa proximal end (104), a distal end (106) and a lumen (108) therebetween.The guide catheter (100) may have any suitable length, diameter, angleof bend, and location of the bend along the length of the catheter(100), to facilitate accessing an ET (26) opening, such as thepharyngeal ostium (28). In some examples, the guide catheter (100) mayhave a length between about 8 cm and about 20 cm, or more particularlybetween about 10 cm and about 15 cm, or more particularly about 11 cm.

FIG. 3B is a cross-sectional view of the elongate tubular shaft (102) ofguide catheter (100). As can be seen, shaft (102) has an outer shafttube (110), an inner shaft tube (112) and a lumen (108). The outer shafttube (110) may be constructed of a stiff material such as stainlesssteel and the inner shaft tube (112) may be constructed of a moreflexible material such as a polymeric material including but not limitedto nylon and further including a PTFE liner. The lumen (108) has adiameter of between about 2 mm and 3 mm, or more particularly betweenabout 2.5 mm and about 2.6 mm, such that the balloon dilation catheter(200) can be easily inserted into the lumen (108) for dilation of the ET(26). The combination of guide catheter (100) and balloon catheter (200)may a compact system that is designed for a one-handed procedure. By“compact,” it is intended that the length of the guide catheter shaftthat is distal of the bend in the guide catheter is between about 0.5and 2.0 about cm, in some versions between about 1 and about 2 cm, andin some versions about 1 cm. The compactness may help reduceinterference with other instruments, such as an endoscope that may beused to help in visualizing the positioning of the system, as describedbelow.

The distal portion (120) of guide catheter (100) is shown in an enlargedview in FIG. 4. The distal portion (120) of the guide catheter (100) mayhave a bend (122) with an angle between about 45 degrees and about 65degrees, and more preferably between about 50 degrees and about 60degrees, and particularly about 55 degrees, to facilitate access intothe ET (26) via the pharyngeal ostium (28). The distal portion (120) ofthe guide catheter (100) is made of a transparent material such as apolymer including but not limited to nylon and PTFE such that balloondilation catheter (200) is visible within the distal portion (120) andsuch that distal portion (120) is more flexible than the elongate shaft(102). The distal tip (124) of the distal portion (120) of the guidecatheter (100) is made of PEBAX® (polyether block amide) such that itprovides for atraumatic access to the ET (26), and may contain 20%barium sulfate or other similar radiopaque materials for visualizableaccess.

Referring again to FIG. 3A, the proximal portion (130) of guide catheter(100) includes a proximal hub (132) to aid in insertion of the ballooncatheter into the ET (26). The hub (132) has a larger diameter proximalend (134) and a smaller diameter middle section (136) to facilitatestabilization of the guide catheter (100) in the nose, rotation of theguide catheter (100), and insertion of the balloon catheter (200) aswill be described in further detail below. The hub (132) isergonomically designed for insertion, location, and rotation throughslight manipulations with one hand.

Balloon dilation catheter (200) of the present example is shown in FIG.5A. The balloon dilation catheter (200) of the present example generallyincludes an elongate shaft (202) having a proximal end (214) and adistal end (218). The balloon dilation catheter (200) further includes aballoon (204) on the distal end (218) of the elongate shaft (202). Theballoon (204) may be a polymer balloon (compliant, semi-compliant, ornon-compliant). In some versions, the balloon (204) comprises a suitablenon-compliant material such as but not limited to polyethyleneterepthalate (PET), PEBAX® (polyether block amide), nylon or the like.The balloon catheter (200) may include any size of balloon including,but not limited to, balloons of 2 mm to 8 mm in diameter or of betweenabout 5 mm and 6 mm (when inflated) and 12 mm to 24 mm in working length(e.g., 2 mm×12 mm, 3.5 mm×12 mm, 5 mm×16 mm, 5 mm×24 mm, 6 mm×16 mm, 6mm×20 mm, 6 mm×24 mm, 7 mm×16 mm, or 7 mm×24 mm). The balloon dilationcatheter (200) generally includes a proximally located connection (230)for inflating/activating the balloon (204) by communicating apressurized medium (e.g., saline) to balloon (204).

Balloon (204) may be expanded to dilate the ET (26) after balloon (204)is placed in a desirable location in the ET (26), as shown in FIGS.10A-10B and described in greater detail below. For example, the openingarea of the ET (26) includes a pharyngeal ostium (28), and dilationcatheter (200) may be advanced to position the balloon in the pharyngealostium (28). An endoscope, such as endoscope (60) (FIGS. 8-9), may beused to assist in positioning the dilation catheter (200). Endoscope(60) may be advanced through the nasal passage to view the dilationcatheter (200). A marker (208) on a shaft of the dilation catheter (200)can be viewed from endoscope (60) to approximate a location of theballoon (204) relative to the opening of the ET (26) (e.g., pharyngealostium (28)) based on a distance of the marker (208) from a proximal endof the balloon (204). Accordingly, dilation catheter (200) can be movedto place marker (208) in a desirable location before expansion of theballoon (204) in the ET (26).

Balloon dilation catheter (200) further includes an actuator (210).Actuator (210) has a proximal side 220 and a distal side (222). In theexample shown in FIG. 5A, actuator (210) is secured by an adhesive toelongate shaft (202). The portion (240) of elongate shaft (202) that isdistal of actuator (210) is sufficiently stiff to be guided through thenasal cavity and into the ET (26) and is constructed of stainless steeland preferably includes a stainless steel hypotube. The portion (238) ofelongate shaft (202) that is proximal of actuator (210) and the portion(250) that is distal to portion (240) is more flexible than the portion(240) and is constructed of a polymeric material including but notlimited to PEBAX® (polyether block amide). In this way, proximal portion(238) of elongate shaft (202) will not interfere with the endoscope (60)described above as it is advanced through the nasal passage, such thatthe dilation catheter (200) can be easily viewed. The actuator (210)allows for easy, ergonomic one-handed advancement of dilation catheter(200) through guide catheter (100) and into the ET (26). Actuator (210)may be used to advance or retract in alternative ways including but notlimited to use of the thumb, the index finger, or a combination offingers (e.g., the index and middle fingers) or the thumb and the indexor middle finger.

The distal end (218) of balloon catheter (200) further includes a tip(212) and a flexible shaft portion (250) that is constructed of apolymeric material including but not limited to PEBAX® (polyether blockamide) that extends from the distal end of the elongate shaft (202) tothe proximal end of balloon (204). In the example shown in FIG. 5A, tip(212) is a bulbous polymeric blueberry shaped, atraumatic tip and isabout 1.5 mm to about 2 mm in length, with an outer diameter of betweenabout 2 mm and about 3 mm. The smoothness and roundness of tip (212)facilitates advancement of the balloon catheter (200) by helping itglide smoothly through the ET (26). Tip (212) further acts as a safetystop. The isthmus (29) of the ET (26), shown in FIG. 1 is approximately1 mm in diameter. The tip (212) diameter is larger than the outerdiameter (233) of the elongate shaft (202) shown in cross-section inFIG. 5B such that the tip (212) size will prevent the balloon catheter(200) from passing through the isthmus (29) into the middle ear (14).

After balloon (204) is positioned within the ET (26) and inflated to anexpanded state (e.g., as shown in FIG. 10B), balloon (204) may be heldin location while in an expanded state for an extended period of time(e.g. several seconds or minutes). The balloon catheter (200) may alsodeliver a substance to the ET (26), such as one or more of thetherapeutic or diagnostic agents described herein. Balloon (204) mayalso carry an expandable stent for delivery into the ET (26) uponexpansion of balloon (204). Balloon dilation catheter (200) and guidecatheter (100) may be removed from the patient after balloon (204) hasbeen deflated/unexpanded. The ET (26) will resume functioning, normallyopening and closing to equalize atmospheric pressure in the middle ear(14) and protect the middle ear (14) from unwanted pressure fluctuationsand loud sounds.

Another exemplary guide catheter (300) is shown in FIG. 7. In thisexample, proximal hub (132) is replaced with a handle (304). Guidecatheter (300) comprises an elongate shaft (302) and a handle (304) toaid in insertion of a balloon catheter, such as balloon catheter (200),into the ET (26) in a manner similar to that described below with regardto the guide catheter (200). In the example shown in FIG. 7, an actuator(306) in the form of a slider is attached to portion of balloon catheter(200) that is contained within handle (304) and is slidably containedwithin elongate shaft (302) of guide catheter (300). Actuator (306) isthus slidable relative to handle (304) along a channel (310) to therebyselectively advance and retract balloon catheter (200) relative toelongate shaft (302). In use, elongate shaft (302) is inserted into theparanasal cavity of the patient and balloon catheter (200) is advancedinto the ET (26) via thumb or single finger advancement of actuator(302) along channel (310) of handle (304). The advancement of ballooncatheter (200) is continued until a visual marker indicates thatadvancement is complete, or until the enlarged tip (212) of ballooncatheter (200) abuts the isthmus of the ET (26); or actuator (302) abutsthe distal end (308) of channel (310) in handle (304) and is thereforefully deployed.

II. EXEMPLARY ENDOSCOPE

Referring to FIGS. 8-9, an endoscope (60) may be used to providevisualization within an anatomical passageway (e.g., within theoro-nasal cavity, etc.) during the process using guide catheter (100)and/or balloon catheter (200) just described, for example. Endoscope(62) of the present example comprises a body (62) and a rigid shaft (64)extending distally from body (62). The distal end of shaft (64) includesa curved transparent window (66). A plurality of rod lenses and lighttransmitting fibers may extend along the length of shaft (64). A lens ispositioned at the distal end of the rod lenses and a swing prism ispositioned between the lens and window (66). The swing prism ispivotable about an axis that is transverse to the longitudinal axis ofshaft (64). The swing prism defines a line of sight that pivots with theswing prism. The line of sight defines a viewing angle relative to thelongitudinal axis of shaft (64). This line of sight may pivot fromapproximately 0 degrees to approximately 120 degrees, from approximately10 degrees to approximately 90 degrees, or within any other suitablerange. The swing prism and window (66) also provide a field of viewspanning approximately 60 degrees (with the line of sight centered inthe field of view). Thus, the field of view enables a viewing rangespanning approximately 180 degrees, approximately 140 degrees, or anyother range, based on the pivot range of the swing prism. Of course, allof these values are mere examples.

As noted above, an endoscope (60) may be used to provide visualizationwithin an anatomical passageway (e.g., within the nasal cavity, etc.)during a process of using dilation catheter system, which in one exampleincludes the balloon dilation catheter (200, 300) and, optionally, guidecatheter (100). As shown in FIGS. 8-9, endoscope (60) of the presentexample comprises a body (62) and a rigid shaft (64) extending distallyfrom body (62). The distal end of shaft (64) includes a curvedtransparent window (66). A plurality of rod lenses and lighttransmitting fibers may extend along the length of shaft (64). A lens ispositioned at the distal end of the rod lenses and a swing prism ispositioned between the lens and window (66). The swing prism ispivotable about an axis that is transverse to the longitudinal axis ofshaft (64). The swing prism defines a line of sight that pivots with theswing prism. The line of sight defines a viewing angle relative to thelongitudinal axis of shaft (64). This line of sight may pivot fromapproximately 0 degrees to approximately 120 degrees, from approximately10 degrees to approximately 90 degrees, or within any other suitablerange. The swing prism and window (66) also provide a field of viewspanning approximately 60 degrees (with the line of sight centered inthe field of view). Thus, the field of view enables a viewing rangespanning approximately 180 degrees, approximately 140 degrees, or anyother range, based on the pivot range of the swing prism. Of course, allof these values are mere examples.

Body (62) of the present example includes a light post (70), an eyepiece(72), a rotation dial (74), and a pivot dial (76). Light post (70) is incommunication with the light transmitting fibers in shaft (64) and isconfigured to couple with a source of light, to thereby illuminate thesite in the patient distal to window (66). Eyepiece (72) is configuredto provide visualization of the view captured through window (66) viathe optics of endoscope (60). It should be understood that avisualization system (e.g., camera and display screen, etc.) may becoupled with eyepiece (72) to provide visualization of the view capturedthrough window (66) via the optics of endoscope (60). Rotation dial (74)is configured to rotate shaft (64) relative to body (62) about thelongitudinal axis of shaft (64). It should be understood that suchrotation may be carried out even while the swing prism is pivoted suchthat the line of sight is non-parallel with the longitudinal axis ofshaft (64). Pivot dial (76) is coupled with the swing prism and isthereby operable to pivot the swing prism about the transverse pivotaxis. Indicia (78) on body (62) provide visual feedback indicating theviewing angle. Various suitable components and arrangements that may beused to couple rotation dial (74) with the swing prism will be apparentto those of ordinary skill in the art in view of the teachings herein.By way of example only, endoscope (60) may be configured in accordancewith at least some of the teachings of U.S. Pub. No. 2010/0030031, thedisclosure of which is incorporated by reference herein. In someversions, endoscope (60) is configured similar to the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif. Othersuitable forms that endoscope (60) may take will be apparent to those ofordinary skill in the art in view of the teachings herein

III. EXEMPLARY METHOD OF TREATING THE EUSTACHIAN TUBE

FIGS. 10A-10B show schematic versions of the guide catheter (100) andballoon catheter (200) being used to treat the ET (26) under visualguidance using endoscope (60). In use, guide catheter (100) may beadvanced into a nostril and through a nasal cavity to position a distalend of the catheter (100) at, in or near the pharyngeal ostium (28),which opens into the ET (26). In some instances, the guide catheter(100) may be passed through a nostril to the ET (26) on the ipsilateral(same side) of the head. In some other instances, the guide catheter(100) may be passed through a nostril to the ET (26) on thecontralateral (opposite side) of the head. A guiding element such as aguidewire (80) or illuminating fiber may be used to aid in accessing theET (26). In some versions, guidewire (80) is omitted.

As shown in FIG. 10B, after guide catheter (100) is in a desiredposition, balloon catheter (200) is advanced through the guide catheter(100) to position balloon (204) of balloon catheter (200) within the ET(26). The physician/user may place the index and middle fingers oneither side of the smaller diameter middle section (136) of proximal hub(132) of guide catheter (100). The physician/user will then place thethumb on the proximal side (220) of actuator (210) or within both sidesof the actuator (210) and will use the thumb to slide the balloondilation catheter (200) through guide catheter (100) to position balloon(204) within the ET (26). Alternatively, the user may grasp proximal hub(132) of guide catheter (100) and use the index finger placed on theproximal side (220) of actuator (210) or in between the distal side(222) and the proximal side (220) of actuator (210) to advance ballooncatheter (200). The larger diameter tip (212) prevents balloon catheter(200) from advancing past the isthmus (29) and into the middle ear (14).Further, distal side (222) of actuator (210) will bottom out againstproximal end (104) of guide catheter (100), such that the ballooncatheter (200) cannot advance any further. The actuator (210) thusprevents the balloon catheter (200) from reaching passing the isthmus(29) and reaching the middle ear (14). Further, actuator (210) can bepositioned at the appropriate distance along the elongate shaft (202)such that access to the ET (26) may be from the contralateral or theipsilateral side.

In an alternative example, a balloon catheter (200) is advanced into anostril of a patient without the use of a guide catheter (100). Theballoon (204) of the balloon catheter (200) is placed within the ET(26). The physician/user will advance the balloon catheter (200) untilthe proximal side (220) of the actuator (210) is adjacent the patient'snostril. The distal side (222) of the actuator (210) will bottom outagainst the patient's nostril, such that the balloon catheter cannotadvance any further. The actuator (210) prevents the catheter frompassing the isthmus (29) and reaching the middle ear (14). Further,actuator (210) can be positioned at the appropriate distance along theelongate shaft (202) such that access to the ET (26) may be from thecontralateral or the ipsilateral side.

Any number of procedures may be carried out following placement of theballoon catheter (200) into the desired position as described above. Forinstance, the Eustachian tube (ET) may be dilated by communicating fluidto balloon (204) and thereby inflating balloon (204), in accordance withthe teachings of various reference cited herein or otherwise. Inaddition or in the alternative, the isthmus (29) may be cleaned and/orotherwise treated as described in U.S. Patent Application No.62/139,919, entitled “Method and Apparatus for Cleaning Isthmus ofEustachian Tube,” filed Mar. 30, 2015, the disclosure of which isincorporated by reference herein.

The elongate shaft (202) contains adjacent dual lumen (232, 234) tubing(see FIG. 5B). By adjacent dual lumen tubing, it is intended that thelumens (232, 234) are next to each other but are spaced apart, one fromthe other. The inflation lumen (232) is used for inflation of theballoon (204) with water, contrast medium, or saline through inflationport (230) to a pressure of between about 3 and about 15 atmospheres, orof between about 6 and about 12 atmospheres. The injection lumen (234)permits the optional injection of water, medicament, or even theintroduction of a guidewire (80) through the injection port (236) at theproximal end (216) of the proximal connector (206). In order to ensurethat inflation port (230) is used for balloon (204) inflation only,inflation port (230) and injection port (236) may optionally havedifferent type connectors. For example, inflation port (230) may be afemale connector whereas injection port (236) is a male connector orvice versa. Alternatively, injection port (236) may have a right-handedthread connector and inflation port (230) may have a left-handed threadconnector or vice versa.

It may be desirable to inject solutions containing contrast agents,pharmaceutically acceptable salt or dosage form of an antimicrobialagent (e.g. antibiotic, antiviral, anti-parasitic, antifungal, etc.), ananesthetic agent with or without a vasoconstriction agent (e.g.Xylocaine with or without epinephrine, Tetracaine with or withoutepinephrine, etc.), an analgesic agent, a corticosteroid or otheranti-inflammatory (e.g. an NSAID), a decongestant (e.g.vasoconstrictor), a mucus thinning agent (e.g. an expectorant ormucolytic), a surfactant, an agent that prevents or modifies an allergicresponse (e.g. an antihistamine, cytokine inhibitor, leucotrieneinhibitor, IgE inhibitor, immunomodulator), an allergen or anothersubstance that causes secretion of mucous by tissues, hemostatic agentsto stop bleeding, antiproliferative agents, cytotoxic agents (e.g.alcohol), biological agents such as protein molecules, stem cells, genesor gene therapy preparations, or the like.

Some nonlimiting examples of antimicrobial agents that may be used inthis invention include acyclovir, amantadine, aminoglycosides (e.g.,amikacin, gentamicin and tobramycin), amoxicillin,amoxicillinlclavulanate, amphotericin B, ampicillin,ampicillinlsulbactam, atovaquone, azithromycin, cefazolin, cefepime,cefotaxime, cefotetan, cefpodoxime, ceflazidime, ceflizoxime,ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol,clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone,dicloxacillin, doxycycline, erythromycin, fluconazole, foscamet,ganciclovir, atifloxacin, imipenemlcilastatin, isoniazid, itraconazole,ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin,penicillin G, pentamidine, pip eracillinitazobactam, rifampin,quinupristindalfopristin, ticarcillinlclavulanate,trimethoprimlsulfamethoxazole, valacyclovir, vancomycin, mafenide,silver sulfadiazine, mupirocin (e.g., Bactroban, Glaxo SmithKline,Research Triangle Park, N.C.), nystatin, triamcinolonelnystatin,clotrimazolelbetamethasone, clotrimazole, ketoconazole, butoconazole,miconazole, tioconazole, detergent-like chemicals that disrupt ordisable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride,menfegol, and N-docasanol); chemicals that block microbial attachment totarget cells and/or inhibits entry of infectious pathogens (e.g.,sulphated and sulphonated polymers such as PC-515 (carrageenan),Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPAgel) that prevent retroviruses from replicating in the cells;genetically engineered or naturally occurring antibodies that combatpathogens such as anti-viral antibodies genetically engineered fromplants known as “plantibodies;” agents which change the condition of thetissue to make it hostile to the pathogen (such as substances whichalter mucosal pH (e.g., Buffer Gel and Acid form); non-pathogenic or“friendly” microbes that cause the production of hydrogen peroxide orother substances that kill or inhibit the growth of pathogenic microbes(e.g., lactobacillus); antimicrobial proteins or peptides such as thosedescribed in U.S. Pat. No. 6,716,813 (Lin et al.,) which is expresslyincorporated herein by reference or antimicrobial metals (e.g.,colloidal silver).

Additionally or alternatively, in some applications where it is desiredto treat or prevent inflammation the substances delivered in thisinvention may include various steroids or other anti-inflammatory agents(e.g., nonsteroidal anti-inflammatory agents or NSAIDS), analgesicagents or antipyretic agents. For example, corticosteroids that havepreviously administered by intranasal 10 administration may be used,such as beclomethasone (Vancenase® or Beconase), flunisolide (Nasalid®),fluticasone proprionate (Flonase®), triamcinolone acetonide (Nasacort®),budesonide (Rhinocort Aqua®), loterednol etabonate (Locort) andmometasone (Nasonex®). Other salt forms of the aforementionedcorticosteroids may also be used. Also, other non-limiting examples ofsteroids that may be useable in the present invention include but arenot limited to aclometasone, desonide, hydrocortisone, betamethasone,clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone,prednicarbate; amcinonide, desoximetasone, diflorasone, fluocinolone,fluocinonide, halcinonide, clobetasol, augmented betamethasone,diflorasone, halobetasol, prednisone, dexarnethasone andmethylprednisolone. Other anti-inflammatory, analgesic or antipyreticagents that may be used include the nonselective COX inhibitors (e.g.,salicylic acid derivatives, aspirin, sodium salicylate, cholinemagnesium trisalicylate, salsalate, diflunisal, sulfasalazine andolsalazine; para-aminophenol derivatives such as acetaminophen; indoleand indene acetic acids such as indomethacin and sulindac; heteroarylacetic acids such as tolmetin, dicofenac and ketorolac; arylpropionicacids such as ibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofenand oxaprozin; anthranilic acids (fenamates) such as mefenamic acid andmeloxicam; enolic acids such as the oxicams (piroxicam, meloxicam) andalkanones such as nabumetone) and Selective COX-2 Inhibitors (e.g.,diaryl-substituted furanones such as rofecoxib; diaryl-substitutedpyrazoles such as celecoxib; indole acetic acids such as etodolac andsulfonanilides such as mmesulide).

Additionally or alternatively, in some applications, such as those whereit is desired to treat or prevent an allergic or immune response and/orcellular proliferation, the substances delivered in this invention mayinclude a) various cytokine inhibitors such as humanized anti-cytokineantibodies, anti-cytokine receptor antibodies, recombinant (new cellresulting from genetic recombination) antagonists, or soluble receptors;b) various leucotriene modifiers such as zafirlukast, montelukast andzileuton; c) immunoglobulin E (IgE) inhibitors such as Omalizumab (ananti-IgE monoclonal antibody formerly called rhu Mab-E25) and secretoryleukocyte protease inhibitor) and d) SYK Kinase inhibitors such as anagent designated as “R-112,” manufactured by Rigel Pharmaceuticals, Inc,South San Francisco, Calif.

Additionally or alternatively, in some applications, such as those whereit is desired to shrink mucosal tissue, cause decongestion, or effecthemostasis, the substances delivered in this invention may includevarious vasoconstrictors for decongestant and or hemostatic purposesincluding but not limited to pseudoephedrine, xylometazoline,oxymetazoline, phenylephrine, epinephrine, etc.

Additionally or alternatively, in some applications, such as those whereit is desired to facilitate the flow of mucous, the substances deliveredin this invention may include various mucolytics or other agents thatmodify the viscosity or consistency of mucous or mucoid secretions,including but not limited to acetylcysteine. In one particular example,the substance delivered by this invention comprises a combination of ananti-inflammatory agent (e.g. a steroid or an NSAID) and a mucolyticagent.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or deter histamine release, the substancesdelivered in this invention may include various mast cell stabilizers ordrugs which prevent the release of histamine such as cromolyn (e.g.,Nasal Chroma) and nedocromil.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or inhibit the effect of histamine, thesubstances delivered in this invention may include variousantihistamines such as azelastine (e.g., Astylin) diphenhydramine,loratidine, etc.

Additionally or alternatively, in some examples such as those where itis desired to dissolve, degrade, cut, break or remodel bone orcartilage, the substances delivered in this invention may includesubstances that weaken or modify bone and/or cartilage to facilitateother procedures of this invention wherein bone or cartilage isremodeled, reshaped, broken or removed. One example of such an agentwould be a calcium chelator such as EDTA that could be injected ordelivered in a substance delivery implant next to a region of bone thatis to be remodeled or modified. Another example would be a preparationconsisting of or containing bone degrading cells such as osteoclasts.Other examples would include various enzymes of material that may softenor break down components of bone or cartilage such as collagenase (CGN),trypsin, trypsinlLEDTA, hyaluronidase, and tosyllysylchloromethane(TLCM).

Additionally or alternatively, in some applications such as thosewherein it is desired to treat a tumor or cancerous lesion, thesubstances delivered in this invention may include antitumor agents(e.g., cancer chemotherapeutic agents, biological response modifiers,vascularization inhibitors, hormone receptor blockers, cryotherapeuticagents or other agents that destroy or inhibit neoplasia ortumorigenesis) such as; alkylating agents or other agents which directlykill cancer cells by attacking their DNA (e.g., cyclophosphamide,isophosphamide), nitrosoureas or other agents which kill cancer cells byinhibiting changes necessary for cellular DNA repair (e.g., carmustine(BCNU) and lomustine (CCNU)), antimetabolites and other agents thatblock cancer cell growth by interfering with certain cell functions,usually DNA synthesis (e.g., 6 mercaptopurine and 5-fluorouracil (5FU),antitumor antibiotics and other compounds that act by binding orintercalating DNA and preventing RNA synthesis (e.g., doxorubicin,daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin) plant(vinca) alkaloids and other antitumor agents derived from plants (e.g.,vincristine and vinblastine), steroid hormones, hormone inhibitors,hormone receptor antagonists and other agents which affect the growth ofhormone-responsive cancers (e.g., tamoxifen, herceptin, aromataseinhibitors such as aminoglutethamide and formestane, trriazoleinhibitors such as letrozole and anastrazole, steroidal inhibitors suchas exemestane), antiangiogenic proteins, small molecules, gene therapiesand/or other agents that inhibit angiogenesis or vascularization oftumors (e.g., meth-I, meth-2, thalidomide), bevacizumab (Avastin),squalamine, endostatin, angiostatin, Angiozyme, AE-941 (Neovastat),CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2,Panzem), carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P),SU6668, SU11248, BMS-275291, COL-3, EMD 121974, 1MC-IC11, 1M862,TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha,interleukin-12 (IL-12) or any of the compounds identified in ScienceVol. 289, Pages 1197-1201 (Aug. 17, 2000) which is expresslyincorporated herein by reference, biological response modifiers (e.g.,interferon, bacillus calmetteguerin (BCG), monoclonal antibodies,interluken 2, granulocyte colony stimulating factor (GCSF), etc.), PGDFreceptor antagonists, herceptin, asparaginase, busulphan, carboplatin,cisplatin, carmustine, cchlorambucil, cytarabine, dacarbazine,etoposide, flucarbazine, fluorouracil, gemcitabine, hydroxyurea,ifosphamide, irinotecan, lomustine, melphalan, mercaptopurine,methotrexate, thioguanine, thiotepa, tomudex, topotecan, treosulfan,vinblastine, vincristine, mitoazitrone, oxaliplatin, procarbazine,streptocin, taxol, taxotere, analogslcongeners and derivatives of suchcompounds as well as other antitumor agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to grow new cells or to modify existing cells, thesubstances delivered in this invention may include cells (mucosal cells,fibroblasts, stem cells or genetically engineered cells) as well asgenes and gene delivery vehicles like plasmids, adenoviral vectors ornaked DNA, mRNA, etc. injected with genes that code foranti-inflammatory substances, etc., and, as mentioned above, osteoclaststhat modify or soften bone when so desired, cells that participate in oreffect mucogenesis or ciliagenesis, etc.

In one example, a local anesthetic, such as Lidocaine is injectedthrough the injection lumen (234) prior to dilation of the ET (26). Theinjection lumen (234) can be used for venting during dilation so thatpressure in the middle ear (14) does not increase or decrease.

IV. EXEMPLARY SYSTEMS FOR DELIVERING ANESTHESIA TO THE EUSTACHIAN TUBE

Use of local anesthesia may improve patient pain management intreatments of the ET (26). Due to the anatomical size constraints of theET (26) and other structures, practitioners must utilize small-sizeneedles to access the ET (26) and adjacent structures. However, existingoff-the-shelf, small-size needles may lack stiffness, pushability, andother advantageous properties that allow a practitioner to readilyaccess and anesthetize the ET (26). Therefore, certain ET (26)treatments and procedures that may otherwise be performed in a lesscostly outpatient (i.e., in-office) setting may end up being performedin a hospital setting under general anesthesia. Improving the currentneedles and systems for delivering anesthesia to the ET (26) maytherefore provide access to a wider population of patients needing ET(26) treatments and increase the comfort of patients receiving in-officeET (26) treatments. The following examples provide various devices andtechniques that may be used to readily deliver anesthetic and/or otherkinds of fluid to an ET (26) without requiring hospitalization of thepatient. Several examples of the various kinds of fluids that may bedelivered using the below-described devices and techniques are referredto above. Other examples of fluids that may be delivered using thebelow-described devices and techniques will be apparent to those ofordinary skill in the art in view of the teachings herein.

A. Exemplary Needle Including Reduced Diameter Distal Portion

FIG. 11 shows an exemplary alternative needle (400) that may be used toaccess and anesthetize the ET (26). Needle (400) may be fluidly coupledwith a source of fluid in a syringe, for example, and directed into theET (26) with or without a guide catheter (100, 300), to deliver ananesthetic fluid to the ET (26). It will be understood that in additionor in the alternative, needle (400) may be utilized to deliver anon-anesthetic, therapeutic fluid and/or any other suitable kinds offluids to the ET (26). As shown, needle (400) includes a proximal end(402), an open distal end (404), and a shaft (406) extendingtherebetween. Needle (400) defines a lumen (409) that extendscontinuously through the length of shaft (406). Proximal end (402)includes a female luer component (407) that is configured to bemechanically and fluidly coupled with a source of fluid, such as asyringe, tubing, etc, such that fluid may be communicated through lumen(409) and out of distal end (404).

In the present example, a first, more proximal portion (408) of shaft(406) includes a first cross-sectional dimension (D₁), and a second,more distal portion (410) of shaft (406) includes a secondcross-sectional dimension (D₂), providing a neck-down at distal portion(410). The first cross-sectional dimension (D₁) is larger than thesecond cross-sectional dimension (D₂), such that proximal portion (408)is relatively stiffer to provide pushability; while distal portion (410)provides flexibility, which may prevent damage to an anatomicalstructure as needle (400) is advanced therethrough. Needle (400)includes sufficient flexibility in order to traverse the bend (122) ofguide catheter (100) (or bends in the anatomy), for example, but alsoincludes sufficient stiffness to provide pushability through guidecatheter (100) and/or the ET (26). In the example shown, shaft (406) andluer component (407) are made from Type 304 Stainless Steel. However,shaft (406) and luer component (407) may instead be made from any othersuitable material(s) as will be understood by persons skilled in the artin view of the teachings herein.

In the present example, the first cross-sectional dimension (D1) isabout 0.050 inches, and the second cross-sectional dimension (D2) isabout 0.0165 inches. In other examples, the first cross-sectionaldimension (D1) may be between about 0.030 inches and about 0.060 inches,while the second cross-sectional dimension (D2) may be between about0.015 inches and about 0.040 inches. In the present example, needle(400) is cylindrical in shape and therefore the first and secondcross-sectional dimensions (D1, D2) are outer diameters of therespective portions (408, 410) of needle (400). In the present example,the inner diameter (i.e., of lumen (409)) at the first portion (408) isabout 0.028 inches, while the inner diameter at the second portion (410)is about 0.008 inches. In other examples, the inner diameter at firstportion (408) may be between about 0.018 inches and about 0.040 inches,while the inner diameter of second portion (410) may be between about0.008 inches and about 0.010 inches. It will be understood that whereneedle (400) includes a cross-sectional shape other than a circle, firstand second cross-sectional dimensions (D1, D2) and inner cross sectionaldimensions (i.e., of lumen (409)) may have other characteristics.

In the present example, needle (400) does not include a taper betweenthe proximal and distal portions (408, 410) and instead includes astepped transition between proximal and distal portions (408, 410). Insome other versions, needle (400) may include a tapered transitionbetween proximal and distal portions (408, 410). Shaft (406) of thepresent example includes a length of about 8 inches, but in otherexamples length of shaft (406) may be between about 6 inches and about10 inches. In the present example, proximal portion (408) includes alength of about 7 inches and distal portion includes a length of about 1inche. Alternatively, proximal portion (408) and distal portion (410)may have any other suitable lengths. For example, proximal portion (408)may include a length of between about 5 inches and about 9 inches, whiledistal portion may include a length of between about 0.5 inches andabout 2.5 inches.

In some examples, it may be advantageous to provide a preformed bend inthe needle to access the ET (26). FIG. 12 shows an exemplary alternativeneedle (420) that is substantially identical to needle (400), except forthat distal end (424) of needle (420) includes a bend (426) in shaft(426), such that a distal portion of needle (420) is disposed at anoblique angle (A) relative to the longitudinal axis (427). In thepresent example, angle (A) is about 20 degrees, but in other examplesmay be between about 5 degrees and about 30 degrees. As shown, a reducedcross-sectional distal portion (430) and part of the largercross-sectional dimension proximal portion (428) is disposed at angle(A) relative to axis (427). In the present example, proximal and distalportions (428, 430) have the cross-sectional dimensions (D1, D2)described above. Moreover, other dimensions of shaft (426) and proximaland distal portions (428, 430) are the same or similar to thosedisclosed with respect shaft (406) and proximal and distal portions(408, 410), respectively.

B. Exemplary Alternative Needle and Sheath Including PredeterminedSpatial Relationship

FIGS. 13-15B show an exemplary alternative needle (500) and sheath (600)that may be utilized with guide catheter (100), as shown in FIG. 15, orguide catheter (300), in order to access and deliver therapeutic fluidsto the ET (26). As discussed in further detail below, in the presentexample, needle (500) and sheath (600) include features that allowsheath (600) to be fixed relative to guide catheter (100) and thatprevent the tip of needle (500) from protruding beyond a predetermineddistance past the distal end of guide catheter (100).

Needle (500) may be fluidly coupled with a source of fluid in a syringe,for example, and directed into the ET (26) under the guidance of sheath(600) and guide catheter (100) to deliver an anesthetic fluid to the ET(26). It will be understood that in addition or in the alternative,needle (500) may be utilized to deliver a non-anesthetic, therapeuticfluid and/or any other suitable kinds of fluids to the ET (26). Asshown, needle (500) includes a proximal end (502), a distal end (504),and a shaft (506) extending therebetween. Needle (500) further defines alumen (509) that extends continuously along the length of shaft (506).Proximal end (502) includes a female luer component (507) that isconfigured to be mechanically and fluidly coupled with a source offluid, such as a syringe, tubing, etc, such that fluid may becommunicated through lumen (509) and out of distal end (504).

In the present example, a first, more proximal portion (508) of shaft(506) includes a first cross-sectional dimension (D₃), and a second,more distal portion (510) of shaft (506) includes a secondcross-sectional dimension (D₄), providing a neck-down at distal portion(510). The first cross-sectional dimension (D₃) is larger than thesecond cross-sectional dimension (D₄), such that proximal portion (508)is relatively stiffer to provide pushability; while the distal portion(510) provides additional flexibility, which may prevent damage to ananatomical structure as needle (500) is advanced therethrough. Needle(500) includes sufficient flexibility in order to traverse the bend(122) of guide catheter (100) (or bends in the anatomy), for example,but also includes sufficient stiffness to provide pushability throughguide catheter (100) and/or the ET (26). In the example shown, shaft(506) and luer component (507) are made from Type 304 Stainless Steel.However, shaft (506) and luer component (507) may instead be made fromany other suitable material(s) as will be understood by persons skilledin the art in view of the teachings herein.

In the present example, first cross-sectional dimension (D₃) is 0.034inches, but in other examples it may be between about 0.03 inches andabout 0.06 inches. Second cross-sectional dimension (D₄) is 0.0165inches, but in other examples it may be between about 0.015 inches andabout 0.040 inches. In the present example, the inner diameter (i.e., oflumen (509)) at the first portion (508) is about 0.025 inches, while theinner diameter at the second portion (510) is about 0.008 inches. Inother examples, the inner diameter at first portion (508) may be betweenabout 0.018 inches and about 0.040 inches, while the inner diameter ofsecond portion (410) may be between about 0.008 inches and about 0.010inches.

As shown, needle (500) includes a stop member (512) that is coupled toshaft (506) and is configured to limit a distal advancement of needle(506) relative to sheath (600) and balloon catheter (200), as discussedin further detail below. In the present example, stop member (512) isfixedly coupled to shaft (506) and includes an elongate first portion(514) having a cross-sectional dimension (D₅) and a length (B); and asecond portion in the form of a circular stop flange (516) positionedproximal to the first portion (514). As shown, flange (516) includes aproximal side (516 a) and distal side (516 b). A third portion (518)extends proximally from flange (516). As shown, shaft (506) extendsdistally from first portion (514) includes a length (A). In the presentexample, the length (A) is approximately 19 cm. Alternatively, any othersuitable length may be used.

As shown in FIG. 14, sheath (600) includes a proximal end (602), adistal end (604), and a shaft (606) extending therebetween. Sheath (600)defines a lumen (609) extending continuously along the length of shaft(606). Proximal end (602) includes a stop hub (608). Stop hub (608)includes an opening (610) extending continuously through hub (608) andin communication with lumen (609). Opening (610) includes a firstportion (612) with a cross-sectional dimension (D₆) and length (E); anda second portion (614) with a cross-sectional dimension (D₇) and length(F). Sheath (600) includes an overall length (C), with shaft (606)including a length of (D) and hub (608) including a length E+F(dimensions E and F are discussed in more detail below). In the presentexample, length C is about 8 inches, but in other examples, it may bebetween about 6 inches and about 10 inches, while length D is about 9inches, but in other examples, it may be between about 7 inches and 10inches. As shown, cross-sectional dimension (D7) is greater thancross-sectional dimension (D6). In the present example, cross-sectionaldimension (D6) is about 0.05 inches, but in other examples, it may bebetween about 0.03 inches and about 0.06 inches.

As shown in FIGS. 15A-15B, needle (500) may be directed into lumen (609)of sheath (600), which may be directed into lumen (108) of ballooncatheter (100), in any sequence. As shown, first portion (612) ofopening (610) is configured to receive first portion (514) of stopmember (512). Therefore, in the present example, cross-sectionaldimension (D₅) is less than cross sectional dimension (D₆). Secondportion (614) of opening (610) is configured to lockingly receiveproximal end (134) of guide catheter (100). In the present example,second portion (614) (i.e., cross-sectional dimension (D₇)) is sizedsuch that proximal end (134) of guide catheter (100) is coupled tosecond portion (614) in an interference fit manner. In other examples,second portion (614) and proximal end (134) may be removably coupled toone another by other suitable features, such as complementary threads,snap fitting, resilient features, etc.

In some examples, needle (500) is directed into sheath (600) prior tothe needle (500) and sheath (600) being directed into guide catheter(100), such that needle (500) and sheath (600) are directed into guidecatheter (100) as a unit. In some other examples, sheath (600) may bedirected into guide catheter (100) prior to needle (500) being insertedinto sheath (600). In any of these examples, guide catheter (100) may bedirected into the oro-nasal cavity with the sheath (600) and needle(500) as a unit; guide catheter (100) may be directed into the oro-nasalcavity alone (i.e., before sheath (600) and needle (500) are disposed inguide catheter (100)).

In the present example, guide catheter (100), needle (500), and sheath(600) are directed into the oro-nasal cavity as a unit, in the mannershown in FIG. 15A, such that no portion of shaft (506) of needle (500)protrudes from distal end (106) of guide catheter (100). Once the guidecatheter (100) is properly placed relative to the ET (26), for example,an operator may advance needle (500) distally relative to sheath (600)and catheter (100) such that distal side (516 b) of flange (516) abutsstop hub (608). In the example shown, needle (500), sheath (600), andguide catheter (100) are sized and configured such that when proximalend (134) of guide catheter (100) is removably coupled to second portion(614) of sheath (600), and when flange (516) abuts stop hub (608), shaft(506) of needle (500) protrudes from distal end (106) of guide catheter(100) a predetermined distance x. Then, an operator may direct fluidthrough lumen (509) and out of distal end of shaft (506) into the ET(26), for example. In the present example, distance x is 10 mm, but inother examples x may be between about 5 mm and about 25 mm.

In the example shown, x=A+B+E−F−l, where l is the overall length ofguide catheter (100). As shown in FIGS. 15A-15B, l=l₁+l₂+s, where l₁equals the length of the portion of guide catheter (100) proximal tobend (120), l₂ equals the length of the portion of guide catheter (100)distal to bend (120), and s equals the length of curved portion at bend(120) of guide catheter (100). It will be understood that

${s = {2\pi \; r\; \frac{\theta_{1}}{360}}},$

with r shown in FIGS. 15A-15B. In the present example, l isapproximately 15.5 cm, but in other examples may be between about 12 cmand about 18 cm. As shown, l₁ is about 14 cm, but in other examples maybe between about 13 cm and about 17 cm, while l₂ is about 1.5 cm, but inother examples may be between about 1 cm and about 3 cm. As shown, s isabout 0.5 cm, but in other examples, s may be between about 0.2 cm andabout 1 cm. Further, as will be understood by person skilled in the art,s depends on angle (θ₁) and radius r. In the present example, θ₁ isbetween about 45 degrees and about 65 degrees, and more preferablybetween about 50 degrees and about 60 degrees, and particularly about 55degrees, to facilitate access into the ET (26) via the pharyngeal ostium(28). However, in other examples, θ₁ may be between about 30 degrees andabout 70 degrees.

In the example shown, A+B is the overall length of the portion of needle(600) distal to stop flange (516), E is the length/depth of secondportion (614) into which proximal end (134) of guide catheter (100) islockingly received, and F is the distance between proximal end of stopmember (608) and the proximal end of second portion (614) (and thus alsothe distance between second side (516 b) of stop flange (516) andproximal end (134) of guide catheter (100) when stop flange (516) abutsstop hub (608) and proximal end (134) of guide catheter (100) isreceived in second portion (614) (FIG. 15B)). As shown, A is about 8inches, but in other examples may be between about 6 inches and about 10inches, while B is about 1 inch, but in other examples may be betweenabout 0.5 inches and about 2.5 inches. As shown, E is about 2 inches,but in other examples, s may be between about 1 inch and about 3 inches.In the present example, F is about 0.25 inches, but in other examplesmay be between about 0.25 inches and about 0.5 inches.

C. Exemplary Alternative Guide Catheter and Modified Needle

FIG. 16 shows an exemplary alternative guide catheter (700). Guidecatheter (700) of the present example includes an elongate tubular shaft(702) that has a proximal end (704), a distal end (706) and a lumen(708) therebetween. The guide catheter (700) may have any suitablelength, diameter, angle of bend, and location of the bend along thelength of the catheter (700), to facilitate accessing an ET (26)opening, such as the pharyngeal ostium (28). In the present example, theguide catheter (700) has a length L, discussed in further detail below.In the example shown, L may be between about 8 cm and about 20 cm, ormore particularly between about 10 cm and about 15 cm, or moreparticularly about 11 cm.

In the present example, shaft (702) is constructed of type 304 stainlesssteel. In addition or in the alternative, shaft (702) may include aninner shaft tube (not shown) constructed of a more flexible materialsuch as a polymeric material including but not limited to nylon andfurther including a PTFE liner. It should also be understood that aproximal portion of shaft (702) may be constructed of a rigid material(e.g., steel) while a distal portion of shaft (702) is constructed of amore flexible material (e.g., polymer). The lumen (708) may have adiameter of between about 2 mm and 3 mm, more particularly between about2.5 mm and about 2.6 mm, such that the balloon dilation catheter (200)can be easily inserted into the lumen (708) for dilation of the ET (26).

The combination of guide catheter (700) and balloon catheter (200) mayprovide a compact system that is designed for a one-handed procedure. By“compact,” it is intended that the length of shaft (702) that is distalof the bend (722) in shaft (702) is between about 0.5 cm and about 2.0cm, in some versions between about 0.7 cm and about 1.7 cm, and in someversions about 1.0 cm. The compactness may help reduce interference withother instruments, such as an endoscope that may be used to help invisualizing the positioning of the system, as described above.

The distal portion (720) of the guide catheter (700) may have a bend(722) with an angle between about 45 degrees and about 65 degrees, andmore particularly between about 50 degrees and about 60 degrees, andmost particularly about 55 degrees, to facilitate access into the ET(26) via the pharyngeal ostium (28). In the present example, distalportion (720) of guide catheter (700) is made of a transparent materialsuch as a polymer including but not limited to nylon and PTFE such thatballoon dilation catheter (200) is visible within distal portion (720)and such that distal portion (720) is more flexible than the remainderof elongate shaft (702). In the present example, distal tip (724) ofdistal portion (720) of guide catheter (700) is made of Type 304stainless steel, and may contain 20% barium sulfate or other similarradiopaque materials for visualizable access. Of course, any othersuitable material(s) may be used.

In the present example, length L of guide catheter (720) equals L1+L2+S,where L1 is the distance between proximal end (734) and proximal end ofbend (722), L2 is the distance between distal end of bend (722) anddistal end (706) and S is the length of curved portion of bend (722). Inthe present example,

${S = {2\pi \; r\; \frac{\theta_{2}}{360}}},$

with r shown in FIG. 16.

Proximal portion (730) of guide catheter (700) includes a proximal hub(732) to aid in insertion of the balloon catheter into the ET (26). Thehub (732) has a larger diameter proximal end (734) and a smallerdiameter middle section (736) to facilitate stabilization of the guidecatheter (700) in the nose, rotation of the guide catheter (700), andinsertion of the balloon catheter (200) as will be described in furtherdetail below. The hub (732) is ergonomically designed for insertion,location, and rotation through slight manipulations with one hand.

FIG. 17 shows an exemplary alternative needle (800) that may be used toaccess and anesthetize the ET (26). Needle (800) may be guided to ET(26) using guide catheter (100, 700). In the present example, needle(800) is sized and configured specifically such that only a portion ofdistal end of needle (800) may protrude distally of distal end of guidecatheter (700), as discussed in further detail below. Needle (400) maybe fluidly coupled with a source of fluid in a syringe, for example, anddirected into the ET (26) with or without a guide catheter (100, 700),to deliver an anesthetic fluid to the ET (26). It will be understoodthat in addition or in the alternative, needle (800) may be utilized todeliver a non-anesthetic, therapeutic fluid and/or any other suitablekinds of fluids to the ET (26).

As shown, needle (800) includes a proximal end (802), a distal end(804), and a shaft (806) extending therebetween. Needle (800) defines alumen (809) that extends continuously along the length of shaft (806).Proximal end (802) includes a female luer component (807) that isconfigured to be mechanically and fluidly coupled with a source offluid, such as a syringe, tubing, etc, such that fluid may becommunicated through lumen (809) and out of distal end (804).

In the present example, a first, more proximal portion (808) of shaft(806) includes a first cross-sectional dimension (D₉), and a second,more distal portion (810) of shaft (806) includes a secondcross-sectional dimension (D₁₀), providing a neck-down at distal portion(810). The first cross-sectional dimension (D₉) is larger than thesecond cross-sectional dimension (D₁₀), such that proximal portion (808)is relatively stiffer to provide pushability; while the distal portion(810) provides flexibility, which may prevent damage to an anatomicalstructure as needle (800) is advanced therethrough. Needle (800)includes sufficient flexibility in order to traverse the bend (122, 722)of guide catheter (100, 700) (or bends in the anatomy), for example, butalso includes sufficient stiffness to provide pushability through guidecatheter (100, 700) and/or the ET (26). In the example shown, shaft(806) and luer component (807) are made from Type 304 Stainless Steel.However, shaft (806) and luer component (807) may instead be made fromany other suitable material(s) as will be understood by persons skilledin the art in view of the teachings herein.

In the present example, the first cross-sectional dimension (D₉) isabout 0.050 inches, and the second cross-sectional dimension (D₁₀) isabout 0.0165 inches. In the present example, needle (800) is cylindricalin shape and therefore the first and second cross-sectional dimensions(D₉, D₁₀) are outer diameters of the respective portions (808, 410) ofneedle (800). In the present example, the inner diameter (i.e., of lumen(809)) at the first portion (808) is about 0.028 inches. Of course, anyother suitable dimensions may be used. It will be understood that whereneedle (800) includes a cross-sectional shape other than a circle, firstand second cross-sectional dimensions (D1, D2) and inner cross sectionaldimensions (i.e., of lumen (809)) may have other characteristics.

As shown in the present example, needle (800) does not include a taperbetween the proximal and distal portions (808, 810) and instead includesa stepped transition between proximal and distal portions (808, 810). Insome other examples, needle (800) may include a tapered transitionbetween proximal and distal portions (808, 810). As shown, needle (806)includes a stop flange (812) that is circular in cross-section and isconfigured to limit the distal advancement of needle (800) relative toguide catheter (700).

In the present example, guide catheter (700) and needle (800) may bedirected into the oro-nasal cavity as a unit, in the manner shown inFIG. 5A, such that no portion of shaft (806) of needle (800) protrudesfrom distal end (706) of guide catheter (700). Once the guide catheter(700) is properly placed relative to the ET (26), for example, anoperator may advance needle (800) distally relative to catheter (700)such that stop flange (812) abuts proximal end (734). In the exampleshown, needle (800) and guide catheter (700) are sized and configuredsuch that when flange (812) abuts proximal end (734) of guide catheter(700), shaft (806) of needle (800) protrudes from distal end (706) ofguide catheter (700) a predetermined distance y. Then, an operator maydirect fluid through lumen (509) and out of distal end of shaft (506)into the ET (26), for example.

In the example shown, y=G−L, discussed above. In some examples, length Gis 8 inches, but any other suitable length may be used.

D. Drug Delivery Catheter Including Distal Apertures and Flow ReducingSponge

FIGS. 18-20 show an exemplary alternative catheter (900) that isconfigured to deliver therapeutic materials in a controlled and precisemanner to various anatomical structures, such as the ET (26) or otherregions associated with the oro-nasal cavity. Catheter (900) may befluidly coupled with a source of fluid in a syringe, for example, anddirected into the ET (26) or other anatomical structures, with orwithout a guide catheter (100), to deliver an anesthetic fluid. It willbe understood that in addition or in the alternative, catheter (900) maybe utilized to deliver a non-anesthetic, therapeutic fluid and/or otherkinds of fluids. As shown, catheter (900) includes a proximal end (902),a distal end (904), and a shaft (906) extending therebetween. Catheter(900) further defines a lumen (909) that extends continuously along thelength of shaft (906).

Proximal end (902) includes a female luer component (907) that isconfigured to be mechanically and fluidly coupled with a source offluid, such as a syringe, tubing, etc, such that fluid may becommunicated through lumen (909) toward distal end (904). As shown,shaft (906) includes uniform inner and outer cross-sectional dimensionsalong the entire length of shaft (906). The materials and/or materialcharacteristics of shaft (906) may be varied in order to providedifferent characteristics at different portions of catheter (900). Forexample, similar to needles discussed above, the cross-sectionaldimensions of catheter (906) along shaft (906) may be varied to providea desired combination of rigidity (e.g., along a proximal portion ofshaft (906)) and flexibility (e.g., along a distal portion of shaft(906)).

In the present example, distal end (904) includes features that preventthe fluid in lumen (909) from rapidly exiting the distal end andtraveling beyond the anatomical location the operator intended.Particularly, shaft (906) includes a plurality of apertures (910) at ornear the distal end (904) of shaft (906) and a flow reducing sponge(914) positioned within lumen (909), coincident with apertures (910). Inthe present example, distal end (904) of catheter (900) includes anopening (912) such that fluid may escape from the apertures (910) andout of distal end opening (912). However, in some examples, distal endof catheter (900) may not include an opening, such that fluid may onlyescape from apertures (910). As shown, apertures (910) extend throughthe wall of the shaft and into the lumen (909). In the present example,catheter (900) includes a longitudinally extending array of sixangularly extending rows of apertures (910) about the circumference ofshaft (906), with each row of apertures (910) being proximally ordistally offset from an adjacent row of apertures (910). In otherexamples, however, there may be more or fewer apertures (910) than shownin any suitable configuration as will be apparent to persons skilled inthe art in view of the teachings herein.

FIGS. 19-20 show sponge member (914) within lumen (909) at distal end(904).

As shown, sponge member (914) is coincident with apertures (910) suchthat in order to flow out of apertures (910), fluid flowing throughcatheter (900) flows through sponge (914). In the present example,sponge (914) is configured to provide a level of fluid resistance toreduce the flow rate of fluid traveling through lumen (909) such thatthe fluid weeps or drips, and does not flow continuously, out of opening(912) and apertures (910). However, in other examples, sponge (914) maybe configured to provide a level of fluid resistance to reduce the flowrate of fluid traveling through lumen (909) such that the fluid flowscontinuously out of apertures (910) and opening (912), but at a lowerflow rate than the fluid would otherwise flow through portions of lumen(909) without sponge (914).

Sponge (909) may be made from one or both of natural or man-madematerials. For example, sponge may be made from cellulose, melamine, orother suitable materials as will be apparent to persons skilled in theart in view of the teachings herein. Sponge (914) may be a woven ornon-woven matrix of material(s), or may be an open or closed cell foamstructure. Additionally or alternatively, sponge (914) may be made fromnatural, dried or moist sponges. Other suitable configurations of sponge(914) will be apparent to persons skilled in the art in view of theteachings herein.

E. Balloon Catheters including Venting Features

Utilizing balloon catheters in the oro-nasal cavity may result inpressure accumulating in certain portions of the cavity. For example,pressure may accumulate in the middle ear (14) during an ET (26)dilation procedure. It may therefore provide comfort for patients toprovide a manner of reducing and equalizing pressure in the middle ear(14), for example, during ET (26) dilation procedures. The followingexamples include devices that have venting features that are configuredto prevent pressure accumulation in the middle ear (14) during an ET(26) treatment. The following devices are also configured to providecommunication of fluid (e.g., anesthetic, therapeutic agents, etc.) tothe ET (26), via the same passageway through which ventilation isprovided or through a separate fluid delivery passageway.

1. Balloon Catheter Including Three Lumens

FIGS. 21A-22 show an exemplary alternative balloon dilation catheter(1200).

Balloon dilation catheter (1200) of the present example generallyincludes an elongate shaft (1202) having a proximal end (1214) and adistal end (1218). Balloon dilation catheter (1200) further includes aballoon (1204) on distal end (1218) of elongate shaft (1202). Balloon(1204) may be a polymer balloon (compliant, semi-compliant, ornon-compliant). In some versions, balloon (1204) comprises a suitablenon-compliant material such as but not limited to polyethyleneterepthalate (PET), PEBAX® (polyether block amide), nylon or the like.Balloon dilation catheter (1200) may include any size of balloonincluding, but not limited to, balloons of 2 mm to 8 mm in diameter orof between about 5 mm and 6 mm (when inflated) and 12 mm to 24 mm inworking length (e.g., 2 mm×12 mm, 3.5 mm×12 mm, 5 mm×16 mm, 5 mm×24 mm,6 mm×16 mm, 6 mm×20 mm, 6 mm×24 mm, 7 mm×16 mm, or 7 mm×24 mm). Balloondilation catheter (1200) generally includes a proximally locatedconnection (1230) for inflating/activating the balloon (1204) bycommunicating a pressurized medium (e.g., saline) to balloon (1204).

Balloon dilation catheter (1200) further includes an actuator (1210).Actuator (1210) has a proximal side (1220) and a distal side (1222). Inthe example shown in FIG. 21A, actuator (1210) is secured by an adhesiveto elongate shaft (1202). The portion (1240) of elongate shaft (1202)that is distal of actuator (1210) is sufficiently stiff to be guidedthrough the nasal cavity and into the ET (26) and is constructed ofstainless steel (e.g., a stainless steel hypotube). The portion (1238)of elongate shaft (1202) that is proximal of actuator (1210) and theportion (1250) that is distal to portion (1240) is more flexible thanthe portion (1240) and is constructed of a polymeric material includingbut not limited to PEBAX® (polyether block amide). In this way, proximalportion (1238) of elongate shaft (1202) will not interfere with theendoscope (60) described above as it is advanced through the nasalpassage, such that dilation catheter (1200) can be easily viewed.Actuator (1210) allows for easy, ergonomic one-handed advancement ofdilation catheter (1200) through guide catheter (100) and into the ET(26). Actuator (1210) may be used to advance or retract in alternativeways including but not limited to use of the thumb, the index finger, ora combination of fingers (e.g., the index and middle fingers) or thethumb and the index or middle finger.

The distal end (1218) of balloon catheter (1200) further includes a tip(1212) and a flexible shaft portion (1250) that is constructed of apolymeric material including but not limited to PEBAX® (polyether blockamide) that extends from the distal end of the elongate shaft (1202) tothe proximal end of balloon (1204). In the example shown in FIG. 21A,tip (1212) is a bulbous polymeric blueberry shaped, atraumatic tip andis about 1.5 mm to about 2 mm in length, with an outer diameter ofbetween about 2 mm and about 3 mm. The smoothness and roundness of tip(1212) facilitates advancement of balloon catheter (1200) by helping itglide smoothly through the ET (26). Tip (1212) further acts as a safetystop. The isthmus (29) of the ET (26), shown in FIG. 1 is approximately1 mm in diameter. Tip (1212) diameter is larger than the outer diameter(1233) of the elongate shaft (1202), shown in cross-section in FIG. 21B,such that tip (1212) size will prevent the balloon catheter (1200) frompassing through the isthmus (29) into the middle ear (14).

Balloon (1204) may be expanded to dilate the ET (26) after balloon(1204) is placed in a desirable location in the ET (26). For example,the opening area of the ET (26) includes a pharyngeal ostium (28), anddilation catheter (1200) may be advanced to position balloon (1204) inthe pharyngeal ostium (28). An endoscope, such as endoscope (60) (FIGS.8-9), may be used to assist in positioning the dilation catheter (1200).Endoscope (60) may be advanced through the nasal passage to viewdilation catheter (1200). A marker (1208) on a shaft of the dilationcatheter (1200) can be viewed from endoscope (60) to approximate alocation of balloon (1204) relative to the opening of the ET (26) (e.g.,pharyngeal ostium (28)) based on a distance of marker (1208) from aproximal end of balloon (1204). Accordingly, dilation catheter (1200)can be moved to place marker (1208) in a desirable location beforeexpansion of balloon (1204) in the ET (26).

Balloon (1204) may be held in location while in an expanded state for anextended period of time (e.g. several seconds or minutes). Balloondilation catheter (1200) may also deliver a substance to the ET (26),such as one or more of the therapeutic or diagnostic agents describedherein. Balloon (1204) may also carry an expandable stent for deliveryinto the ET (26) upon expansion of balloon (1204). Balloon dilationcatheter (1200) and guide catheter (100) may be removed from the patientafter balloon (1204) has been deflated/unexpanded. The ET (26) willresume functioning, normally opening and closing to equalize atmosphericpressure in the middle ear (14) and protect the middle ear (14) fromunwanted pressure fluctuations and loud sounds.

In the present example, elongate shaft (1202) contains adjacent triplelumen (1232, 1234, 1236) tubing (see FIG. 21B). By adjacent triple lumentubing, it is intended that the lumens (1232, 1234, 1236) are next toeach other but are spaced apart, one from the other. The inflation lumen(1232) is used for inflation of balloon (1204) with water, contrastmedium, or saline through inflation port (1230) to a pressure of betweenabout 3 and about 15 atmospheres, or of between about 6 and about 12atmospheres.

Injection lumen (234) permits the optional injection of anesthetic, atherapeutic agent, some other fluid, or even the introduction of aguidewire (80) or any of the needles described herein, through theinjection port (1236) at the proximal end (1216) of the proximalconnector (1206). It should therefore be understood that injection lumen(234) may be used to deliver fluid to the ET (26) while ventilationlumen (1236) provides ventilation to the ET (26). As yet another merelyillustrative variation, ventilation lumen (1236) may be used tocommunicate fluid (e.g., an anesthetic, a therapeutic agent, and/or someother fluid) to the ET (26) after ventilation lumen (1236) has providedventilation to the ET (26).

In order to ensure that inflation port (1230) is used for balloon (1204)inflation only, inflation port (1230) and injection port (1236) mayoptionally have different type connectors. For example, inflation port(1230) may be a female connector whereas injection port (1236) is a maleconnector or vice versa. Alternatively, injection port (1236) may have aright-handed thread connector and inflation port (1230) may have aleft-handed thread connector or vice versa.

Ventilation lumen (1236) extends from a lateral opening (1239) in shaft(1202) that is distal to the distal bond of balloon (1204), along thelength of shaft (1202), and proximally terminates at lateral ventilationport (1238). Therefore, fluids (air, liquids) may travel through lateralopening (1239), along ventilation lumen (1236), and out of port (1238)to equalize pressure in an area that is positioned distal to balloon(1204). For example, when balloon catheter (1200) is utilized in an ETdilation procedure such as that shown in FIGS. 10A-10C, ventilationlumen (1236) may assist in equalizing pressure in middle ear (14) duringthe inflation of balloon (1204).

2. Balloon Dilation Catheter with Ventilation Lumen Extending AlongBalloon Length

FIGS. 23A-23C show another exemplary alternative balloon catheter(1300).

Balloon catheter (1300) is substantially identical to balloon catheter(200) in several respects. For instance, balloon catheter (1300)includes an alternative shaft (1302) including inflation lumen (232) andinjection lumen (234) that are configured in accordance with lumens(232, 234) of balloon catheter (200). However, unlike balloon catheter(200), balloon catheter (1300) of this example includes a ventilationlumen (1336) extending along the length of the balloon (204). As shownin the present example, a first, proximal end (1338) of ventilationlumen (1336) terminates distal to the proximal balloon bond, and asecond, distal end (1340) terminates proximal to tip (212) but distal toballoon (204). Therefore, fluids (air, liquids) may travel throughsecond end (1340) of ventilation lumen (1336) and out of first end(1338) to equalize pressure in an area that is positioned distal toballoon (204). For example, when balloon catheter (1300) is utilized inan ET (26) dilation procedure such as that shown in FIGS. 10A-10C,ventilation lumen (1336) may assist in equalizing pressure in middle ear(14) during the inflation of balloon (204), due to the position of firstend (1338) being located proximal to balloon (204).

Injection lumen (234) permits the optional injection of anesthetic, atherapeutic agent, some other fluid, or even the introduction of aguidewire (80) or any of the needles described herein, through aninjection port at the proximal end of balloon catheter (1300). It shouldtherefore be understood that injection lumen (234) may be used todeliver fluid to the ET (26) while ventilation lumen (1336) providesventilation to the ET (26).

3. Balloon Dilation Catheter with Ventilation Lumen Extending AlongBalloon Length and Including Apertures in Shaft

FIGS. 24A-24C show another exemplary alternative balloon catheter(1400). Balloon catheter (1400) is substantially identical to ballooncatheter (200) in several respects. For instance, balloon catheter(1400) includes an alternative shaft (1402) including inflation lumen(232) and injection lumen (234) that are configured in accordance withlumens (232, 234) of balloon catheter (200). However, unlike ballooncatheter (200), balloon catheter (1400) of this example includes aventilation lumen (1436) extending along the length of the balloon(204). As shown in the present example, a first, proximal end (1438) ofventilation lumen (1436) terminates distal to the proximal balloon bond,and a second, distal end (1440) terminates proximal to tip (212) butdistal to balloon (204).

In the present example, ventilation lumen (1436) includes a plurality oflateral apertures (1442) near the first end (1438). Therefore, fluids(air, liquids) may travel through second end (1440) of ventilation lumen(1436) and out of first end (1438) and apertures (1442) to equalizepressure in an area that is positioned distal to balloon (204). Forexample, when balloon catheter (1400) is utilized in an ET dilationprocedure such as that shown in FIGS. 10A-10C, ventilation lumen (1436)may assist in equalizing pressure in middle ear (14) during theinflation of balloon (204), due to the position of first end (1338)being located proximal to balloon (204).

Injection lumen (234) permits the optional injection of anesthetic, atherapeutic agent, some other fluid, or even the introduction of aguidewire (80) or any of the needles described herein, through aninjection port at the proximal end of balloon catheter (1400). It shouldtherefore be understood that injection lumen (234) may be used todeliver fluid to the ET (26) while ventilation lumen (1436) providesventilation to the ET (26).

4. Balloon Dilation Catheter with Enlarged Ventilation and InjectionLumen

FIGS. 25A-25B show another exemplary alternative balloon catheter(1500). Balloon catheter (1500) is substantially similar to ballooncatheter (200), except that balloon catheter (1500) includesventilation, injection, and inflation features, discussed in more detailbelow. Balloon dilation catheter (1500) of the present example generallyincludes an elongate shaft (1502) having a proximal end (1514) and adistal end (1518). Balloon dilation catheter (1500) further includes aballoon (1504) on distal end (1518) of elongate shaft (1502). Balloon(1504) may be a polymer balloon (compliant, semi-compliant, ornon-compliant). In some versions, balloon (1504) comprises a suitablenon-compliant material such as but not limited to polyethyleneterepthalate (PET), PEBAX® (polyether block amide), nylon, or the like.Balloon catheter (1500) may include any size of balloon including, butnot limited to, balloons of 2 mm to 8 mm in diameter or of between about5 mm and 6 mm (when inflated) and 12 mm to 24 mm in working length(e.g., 2 mm×12 mm, 3.5 mm×12 mm, 5 mm×16 mm, 5 mm×24 mm, 6 mm×16 mm, 6mm×20 mm, 6 mm×24 mm, 7 mm×16 mm, or 7 mm×24 mm). Balloon dilationcatheter (1500) generally includes a proximally located connection(1530) for inflating/activating the balloon (1504) by communicating apressurized medium (e.g., saline) to balloon (1504).

Balloon dilation catheter (1500) further includes an actuator (1510).Actuator (1510) has a proximal side (1520) and a distal side (1522). Inthe example shown in FIG. 25A, actuator (1510) is secured by an adhesiveto elongate shaft (1502). The portion (1540) of elongate shaft (1502)that is distal of actuator (1510) is sufficiently stiff to be guidedthrough the nasal cavity and into the ET (26) and is constructed ofstainless steel (e.g., a stainless steel hypotube). The portion (1538)of elongate shaft (1502) that is proximal of actuator (1510) and theportion (1550) that is distal to portion (1540) is more flexible thanthe portion (1540) and is constructed of a polymeric material includingbut not limited to PEBAX® (polyether block amide). In this way, proximalportion (1538) of elongate shaft (1502) will not interfere withendoscope (60) described above as it is advanced through the nasalpassage, such that dilation catheter (1500) can be easily viewed.Actuator (1510) allows for easy, ergonomic one-handed advancement ofdilation catheter (1500) through guide catheter (100) and into the ET(26). Actuator (1510) may be used to advance or retract in alternativeways including but not limited to use of the thumb, the index finger, ora combination of fingers (e.g., the index and middle fingers) or thethumb and the index or middle finger.

Distal end (1518) of balloon catheter (1500) further includes a tip(1512) and a flexible shaft portion (1550) that is constructed of apolymeric material including but not limited to PEBAX® (polyether blockamide) that extends from the distal end of the elongate shaft (1502) tothe proximal end of balloon (1504). In the present example, tip (1512)is a bulbous polymeric blueberry shaped, atraumatic tip and is about 1.5mm to about 2 mm in length, with an outer diameter of between about 2 mmand about 3 mm. The smoothness and roundness of tip (1512) facilitatesadvancement of balloon catheter (1500) by helping it glide smoothlythrough the ET (26). Tip (1512) further acts as a safety stop. Theisthmus (29) of the ET (26), shown in FIG. 1 is approximately 1 mm indiameter. Tip (1512) diameter is larger than the outer diameter (1533)of elongate shaft (1502) such that tip (1512) size will prevent ballooncatheter (1500) from passing through the isthmus (29) into the middleear (14).

Balloon (1504) may be expanded to dilate the ET (26) after balloon(1504) is placed in a desirable location in the ET (26). For example,the opening area of the ET (26) includes a pharyngeal ostium (28), anddilation catheter (1500) may be advanced to position the balloon in thepharyngeal ostium (28). An endoscope, such as endoscope (60) (FIGS.8-9), may be used to assist in positioning dilation catheter (1500).Endoscope (60) may be advanced through the nasal passage to viewdilation catheter (1500). A marker (1508) shaft (1502) of dilationcatheter (1500) can be viewed from endoscope (60) to approximate alocation of balloon (1504) relative to the opening of the ET (26) (e.g.,pharyngeal ostium (28)) based on a distance of marker (1508) from aproximal end of the balloon (1504). Accordingly, dilation catheter(1500) can be moved to place marker (1508) in a desirable locationbefore expansion of balloon (1504) in the ET (26).

In the present example, elongate shaft (1502) contains adjacent duallumen (1532, 1534) tubing. By adjacent dual lumen tubing, it is intendedthat the lumens (1532, 1534) are next to each other but are spacedapart, one from the other, as shown in FIG. 25B. As shown in FIG. 25A,balloon catheter (1500) includes a proximal hub (1506) that is similarto hub (206), except for that inflation port (1530) includes an elongatetube (1540) extending proximally from hub (1506). Elongate tube (1540)includes a first portion (1542) extending at an oblique angle (θ₂)relative to the longitudinal axis of balloon catheter (1500) and asecond portion (1544) extending parallel to the longitudinal axis ofballoon catheter (1500). Inflation tube (1530) further includes a femaleluer (1546) at the end of tube (1530) adjacent to second portion (1544).

Inflation lumen (1532) is used for inflation of the balloon (1504) withwater, contrast medium, or saline through inflation port (1530) to apressure of between about 3 and about 15 atmospheres, or of betweenabout 6 and about 12 atmospheres. Inflation lumen extends from thedistal most portion of first portion (1542) of tube (1540) andterminates at an opening on shaft (1502) within balloon (1504).

Injection lumen (1534) extends from port (1536) and through the entirelength of shaft (1502) and terminates at an opening in tip (1512). Lumen(1534) permits the injection of water, medicament, or even theintroduction of a guidewire (80) or any of the needles described herein,through the injection port (236) at the proximal end (1516) of theproximal hub (1506). Lumen (1534) is sized and configured such that suchthat there is open space for ventilation through lumen (1534) even whenthe lumen is occupied with a guidewire (80) or any of the needlesdescribed herein. In the present example, lumen (1534) is sized toremain fully open if the guidewire (80), needle, or other insertedinstrument is not extended distally; and will stay open, but with lessluminal space when the guidewire (80), needle, or other insertedinstrument is extended distally within lumen (1534).

Due to the configuration of lumen (1534), fluids (air, liquids) maytravel through tip (1512) into lumen and out of port (1536). Forexample, when balloon catheter (1500) is utilized in an ET (26) dilationprocedure such as that shown in FIGS. 10A-10C, lumen (1534) may assistin equalizing pressure in middle ear (14) during the inflation ofballoon (1504), due to the position of port (1536) being locatedproximal to balloon (1504). Lumen (1534) may thus be used to communicatefluid (e.g., an anesthetic, a therapeutic agent, and/or some otherfluid) to the ET (26) in addition to providing ventilation to the ET(26).

Balloon (1504) may be held in location while in an expanded state for anextended period of time (e.g. several seconds or minutes). Ballooncatheter (1500) may also deliver a substance to the ET (26), such as oneor more of the therapeutic or diagnostic agents described herein.Balloon (1504) may also carry an expandable stent for delivery into theET (26) upon expansion of balloon (1504). Balloon dilation catheter(1500) and guide catheter (100) may be removed from the patient afterballoon (1504) has been deflated/unexpanded. The ET (26) will resumefunctioning, normally opening and closing to equalize atmosphericpressure in the middle ear (14) and protect the middle ear (14) fromunwanted pressure fluctuations and loud sounds.

V. EXEMPLARY COMBINATIONS

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A system for delivering a fluid to a Eustachian tube (ET) of a patient,the system comprising: (a) a guide member, wherein the guide membercomprises a shaft having a proximal portion and a distal portion,wherein the guide member further comprises a bend at the distal portion,wherein the bend is configured to provide access to an opening in theET; and (b) a tubular member comprising a proximal end, a distal end,and a lumen extending therebetween, wherein the tubular member is sizedto fit within the ET, wherein one or both of the tubular member andguide member comprises a first stop member configured to engage theother of the tubular member or the guide member, wherein the first stopmember is configured to restrict a distal advancement of the tubularmember relative to the guide member.

Example 2

The system of Example 1, wherein the tubular member comprises a proximalportion and a distal portion, wherein the proximal portion is stifferthan the distal portion.

Example 3

The system of any one or more of Examples 1 through 2, wherein thetubular member comprises a proximal portion having a firstcross-sectional dimension and a distal portion comprising a secondcross-sectional dimension, wherein the first cross-sectional dimensionis greater than the second cross-sectional dimension.

Example 4

The system of Example 3, wherein the first cross sectional dimension isbetween about 0.30 inches and about 0.060 inches, wherein the secondcross-sectional dimension is between about 0.015 inches and about 0.040inches.

Example 5

The system of any one or more of Examples 1 through 4, wherein the firststop member is configured to prevent the distal end of the tubularmember from extending past the distal portion of the guide member apredetermined amount.

Example 6

The system of Example 5, wherein the predetermined amount comprisesbetween about 5 mm and about 25 mm.

Example 7

The system of any one or more of Examples 1 through 6, wherein the stopmember comprises a flange on the tubular member.

Example 8

The system of any one or more of Examples 1 through 7, wherein the stopmember comprises a proximal portion of the guide catheter.

Example 9

The system of any one or more of Examples 1 through 8, furthercomprising a sheath, wherein the tubular member is configured to beinserted into the sheath and the sheath is configured to be insertedinto the guide member.

Example 10

The system of Example 9, wherein the sheath is configured to lockinglyreceive the proximal portion of the guide member to prevent relativemovement between the sheath and the guide member.

Example 11

The system of any one or more of Examples 9 through 10, furthercomprising a second stop member, wherein the second stop member isdisposed on the sheath.

Example 12

The system of any one or more of Examples 9 through 11, wherein thesheath includes a hub including a recess, wherein the recess isconfigured to receive the proximal portion of the guide member.

Example 13

The system of any one or more of Examples 1 through 12, wherein thetubular member comprises a preformed bend at or near the distal end.

Example 14

The system of any one or more of Examples 1 through 13, wherein theshaft of the guide member consists essentially of stainless steel.

Example 15

The system of any one or more of Examples 1 through 14, wherein thetubular member comprises a plurality of apertures at or near the distalend, wherein the tubular member comprises a flow limiting memberdisposed in the lumen, wherein the flow limiting coincident with atleast a portion of the apertures.

Example 16

The system of Example 15, wherein the flow limiting element comprises asponge member.

Example 17

A method of treating a Eustachian tube (ET) of a patient using a guidemember and a tubular member, wherein one or both of the guide member andtubular member comprises a stop member configured to limit a restrictadvancement of the tubular member relative to the guide member, whereinthe method comprises: (a) directing the guide member into an oro-nasalcavity of the patient; (b) directing the tubular catheter into theoro-nasal cavity of the patient; (c) advancing at least part of a distalportion of the guide member adjacent to or into an opening of the ET;(d) advancing the tubular member relative to the guide member such thata distal end of the tubular member is positioned coincident with atleast a portion of the ET; and (e) directing a fluid through the tubularmember and out of the tubular member and onto at least a portion of theET.

Example 18

The method of Example 17, wherein the fluid comprises an anesthetic.

Example 19

A method of treating a Eustachian tube (ET) of a patient using a guidemember and a dilation catheter, wherein the method comprises: (a)directing the guide member into an oro-nasal cavity of the patient; (b)directing the dilation catheter into the oro-nasal cavity of thepatient; (c) advancing at least part of a distal portion of the guidemember into an opening of the ET; (d) advancing the dilation catheterrelative to the guide member such that an expandable element of thedilation catheter is positioned distal to a distal end of the guidemember; (e) expanding the expandable member to thereby dilate the ET;(f) venting the anatomical structures that are positioned distal to theexpandable member; and (g) delivering a fluid to the ET.

Example 20

The method of Example 19, wherein the dilation catheter comprises aventilation lumen including a first opening positioned distal to theexpandable element and a second opening positioned proximal to theexpandable element.

VI. MISCELLANEOUS

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, examples, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, examples,examples, etc. that are described herein. The above-described teachings,expressions, examples, examples, etc. should therefore not be viewed inisolation relative to each other. Various suitable ways in which theteachings herein may be combined will be readily apparent to those ofordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a userimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various examples of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, examples, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. A system for delivering a fluid to a Eustachian tube (ET)of a patient, the system comprising: (a) a guide member, wherein theguide member comprises a shaft having a proximal portion and a distalportion, wherein the guide member further comprises a bend at the distalportion, wherein the bend is configured to provide access to an openingin the ET; and (b) a tubular member comprising a proximal end, a distalend, and a lumen extending therebetween, wherein the tubular member issized to fit within the ET, wherein one or both of the tubular memberand guide member comprises a first stop member configured to engage theother of the tubular member or the guide member, wherein the first stopmember is configured to restrict a distal advancement of the tubularmember relative to the guide member.
 2. The system of claim 1, whereinthe tubular member comprises a proximal portion and a distal portion,wherein the proximal portion is stiffer than the distal portion.
 3. Thesystem of claim 1, wherein the tubular member comprises a proximalportion having a first cross-sectional dimension and a distal portioncomprising a second cross-sectional dimension, wherein the firstcross-sectional dimension is greater than the second cross-sectionaldimension.
 4. The system of claim 3, wherein the first cross sectionaldimension is between about 0.30 inches and about 0.060 inches, whereinthe second cross-sectional dimension is between about 0.015 inches andabout 0.040 inches.
 5. The system of claim 1, wherein the first stopmember is configured to prevent the distal end of the tubular memberfrom extending past the distal portion of the guide member apredetermined amount.
 6. The system of claim 4, wherein thepredetermined amount comprises between about 5 mm and about 25 mm. 7.The system of claim 1, wherein the stop member comprises a flange on thetubular member.
 8. The system of claim 1, wherein the stop membercomprises a proximal portion of the guide catheter.
 9. The system ofclaim 1, further comprising a sheath, wherein the tubular member isconfigured to be inserted into the sheath and the sheath is configuredto be inserted into the guide member.
 10. The system of claim 9, whereinthe sheath is configured to lockingly receive the proximal portion ofthe guide member to prevent relative movement between the sheath and theguide member.
 11. The system of claim 9, further comprising a secondstop member, wherein the second stop member is disposed on the sheath.12. The system of claim 9, wherein the sheath includes a hub including arecess, wherein the recess is configured to receive the proximal portionof the guide member.
 13. The system of claim 1, wherein the tubularmember comprises a preformed bend at or near the distal end.
 14. Thesystem of claim 1, wherein the shaft of the guide member consistsessentially of stainless steel.
 15. The system of claim 1, wherein thetubular member comprises a plurality of apertures at or near the distalend, wherein the tubular member comprises a flow limiting memberdisposed in the lumen, wherein the flow limiting coincident with atleast a portion of the apertures.
 16. The system of claim 15, whereinthe flow limiting element comprises a sponge member.
 17. A method oftreating a Eustachian tube (ET) of a patient using a guide member and atubular member, wherein one or both of the guide member and tubularmember comprises a stop member configured to limit a restrictadvancement of the tubular member relative to the guide member, whereinthe method comprises: (a) directing the guide member into an oro-nasalcavity of the patient; (b) directing the tubular catheter into theoro-nasal cavity of the patient; (c) advancing at least part of a distalportion of the guide member adjacent to or into an opening of the ET;(d) advancing the tubular member relative to the guide member such thata distal end of the tubular member is positioned coincident with atleast a portion of the ET; and (e) directing a fluid through the tubularmember and out of the tubular member and onto at least a portion of theET.
 18. The method of claim 17, wherein the fluid comprises ananesthetic.
 19. A method of treating a Eustachian tube (ET) of a patientusing a guide member and a dilation catheter, wherein the methodcomprises: (a) directing the guide member into an oro-nasal cavity ofthe patient; (b) directing the dilation catheter into the oro-nasalcavity of the patient; (c) advancing at least part of a distal portionof the guide member into an opening of the ET; (d) advancing thedilation catheter relative to the guide member such that an expandableelement of the dilation catheter is positioned distal to a distal end ofthe guide member; (e) expanding the expandable member to thereby dilatethe ET; (f) venting the anatomical structures that are positioned distalto the expandable member; and (g) delivering a fluid to the ET.
 20. Themethod of claim 19, wherein the dilation catheter comprises aventilation lumen including a first opening positioned distal to theexpandable element and a second opening positioned proximal to theexpandable element.